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Clinical Trials with Allogeneic Cultured Dermal Substitutes (CDS) for Treatment of Skin Ulcers (Regenerating Medical Millennium Project of the Ministry of Health, Labor and Welfare)
Author(s) -
Koichi Hirotomi,
Taro Mikami,
Kensaku Ohki,
Kayo Daigo,
Jiro Maegawa,
Katsuyuki Torikai,
Kentarou Kubo,
Hiromichi Matsui,
Yoshimitsu Kuroyanagi
Publication year - 2004
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1067-1927.2004.abstractav.x
Subject(s) - medicine , christian ministry , clinical trial , surgery , granulation tissue , refractory (planetary science) , dermatology , wound healing , philosophy , physics , theology , astrobiology
Aim: Multi‐center's clinical study, using allogeneic CDS are proceeded in 30 hospitals as the Millennium Project of the Ministry of Health, Labor and Welfare. The clinical trial in our hospital was designed to evaluate the efficacy of CDS for the treatment of refractory skin ulcers. Methods: The application of CDS on the debrided wound was repeated at an interval of 3 to 5 days. The evaluation was performed according to the protocol, especially focused on granulation tissue formation, wound size reduction, and epithelialization. Results: The clinical trials were conducted in 6 cases, including 5 cases with various complications, i.e., diabetes (2 cases), collagen diseases (1 case), renal failure (1 case), and skin defect after resection of tumor (1 case). According to the comprehensive judgement, 5 cases were evaluated as achieving excellent, and 1 case was evaluated as achieving good. Conclusion: The successful application of CDS is dependent on the control of wound conditions free from infection. Appropriate debridment was necessary prior to application of CDS.